S2O

S2O converts IBM SPSS Statistics datasets into the CDISC Operational Data Model (ODM) format to enable standardized representation, archival, and regulatory-compliant exchange of clinical trial and patient data.

Key Features:

• Data Conversion: Maps SPSS variables and patient values to the CDISC ODM structure to convert SPSS datasets into ODM-compliant data.
• Syntactic and Semantic Validation: Performs syntactic and semantic checks during transformation and validates outputs using various ODM tools and reverse transformations from ODM back into SPSS.
• Command-Line Implementation: Executes conversion as a command-line tool via an internal Java plugin within SPSS.
• Regulatory Compliance: Produces CDISC ODM output to support regulatory requirements for electronic data capture (EDC), including secure and auditable data collection.
• EDC Migration Facilitation: Facilitates migration from spreadsheet-based systems such as Excel and SPSS to EDC systems that support multi-user and multicenter trials while preserving audit trails.

Scientific Applications:

• EDC Integration: Enables transfer of legacy SPSS and spreadsheet datasets into CDISC ODM for integration with regulated EDC platforms used in clinical trials.
• Standardized Archival: Supports standardized archival and exchange of clinical trial meta-data and patient data using the CDISC ODM standard.
• Data Integrity and Compliance: Supports auditable, regulatory-compliant data management to enhance the integrity and reliability of clinical trial data.

Methodology:

Implements a mapping model between SPSS and CDISC ODM data structures to address non-corresponding statistical/display attributes and missing study-related ODM elements; performs transformations via an internal Java plugin callable from the command line and validates results using ODM tools and reverse transformations to SPSS.